Effects of High-frequency Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Cerebral Small Vessel Disease

Transcranial Magnetic Stimulation Clinical Trial

Official title:

Effects of High-frequency Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Cerebral Small Vessel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05914623
• Other study ID #: TMSCA-CSVD
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD,PhD
• Phone: 13756661217
• Email: doctoryangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to investigate the effect of high-frequency repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with cerebral small vessel disease.

Description:

Current studies have shown that repetitive transcranial magnetic stimulation can change the excitability of nerve cells, improve intracerebral artery blood supply, and even reduce the degree of neurological impairment in patients with stroke. The purpose of this study was to investigate the effect of high-frequency repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with cerebral small vessel disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 18-80 years, regardless of gender;

2. Diagnosed with CSVD, and neuroimaging presented as recent small subcortical infarcts;

3. Initiated transcranial magnetic stimulation within 7 days of onset;

4. Subject or legal representative agreed to the treatment and signed the informed consent;

Exclusion Criteria:

1. Vascular stenosis > 50% diagnosed by Transcranial Doppler (TCD) and carotid ultrasound;

2. Previous history of atrial fibrillation or myocardial infarction within 6 months;

3. Moyamoya disease or hereditary cerebral small vessel disease, such as CADASIL;

4. White matter hyperintensities (WMH) of non-vascular origin;

5. Severe hepatic and renal diseases, cancer or other major diseases related to integral medical and surgical procedures;

6. Patients with contraindications to transcranial magnetic stimulation, such as metal or electronic devices in the brain;

7. Pregnant or breastfeeding women;

8. The patients with disorders of consciousness, agitation or insufficient bilateral temporal bone windows for insonation who cannot cooperate to dynamic cerebral autoregulation monitoring;

9. Previous history of epilepsy or family history of epilepsy;

10. Previous treatment with transcranial magnetic stimulation or its equivalent;

11. Unwillingness to be followed up or poor adherence to treatment;

12. Those who are participating in other clinical investigators, or who have participated in other clinical studies within 3 months prior to enrollment, or who have participated in this study;

13. Other conditions that the investigators deemed unsuitable for enrollment.

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• Transcranial Magnetic Stimulation

Intervention

Procedure:
• Repetitive transcranial magnetic stimulation
After enrollment, the patients received rTMS once a day for 5 consecutive days (stimulation plan: stimulation of M1 region on the affected side at 10Hz).
• Sham repetitive transcranial magnetic stimulation
After enrollment, the patients received sham-rTMS once a day for 5 consecutive days with the same parameters as the rTMS group, but the coil was rotated 90° away from the scalp.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	phase difference (PD) in degree	A cerebral autoregulation parameter derived from transfer function analysis. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the cerebral autoregulatory parameter.	0-5 days